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The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation in daily life.
This study aims to determine, in patients after stroke, the optimal affected upper limb recovery threshold at rehabilitation discharge to predict spontaneous level of use of affected upper limb in activities of daily living, six month later.
This study is a multicentric prognostic prospective cohort study. The main prognostic variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6 months post discharge.
Adults after stroke will be recruited at post-acute rehabilitation discharge. Three evaluation times will be undertaken: at discharge, three and six months after discharge. Evaluation battery will focus on the three level of the Functioning International Classification: affected upper limb level of strength, proprioception and level of functional recovery, hemineglect, depression, cognition status, and activity level by doing a standardised instrumental task of daily living, and level of participation questionnaire. General characteristics will be taken into account: Age, social status, laterality.
At six months, the spontaneous level of affected upper arm use in daily living will also be assessed using accelerometers.
As the main aim of the study is to build a prediction model, the study size is calculated to observe a minimal number of events by potentially predictive variable. We consider here 7.5 events by independent variable (Vittinghof and McCulloch, 2007) and eight independent variables. According to literature review, we estimated that 35% of adults included in this study would spontaneously use their affected upper arm in activities of daily living six months after discharge. According to these data and considering 10% of protocol deviations, we calculated that 192 subjects will have to be included in the study. The inclusion duration will be 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stroke |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scale Action Research Arm Test (ARAT) | Diagnostic Test | Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity | Score of Motor Activity Log scale | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Action Arm | Score of Action Research Arm Test scale | Day 0 |
| Action Arm | Score of Action Research Arm Test scale | Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible to participate in the study will be adults who have experienced a first stroke and are about to leave the rehabilitation facility for their home. These people should have a good oral comprehension. They must not have a psychiatric history with hospitalization of more than 6 months. They must have been independent in the activities of daily life before their stroke. They must be affiliated to a social security scheme, be willing to participate in the study and not participate in another research.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric SORITA, PhD | Contact | +33557820967 | eric.sorita@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric SORITA, PhD | University Hospital, Bordeaux | Principal Investigator |
| Paul PEREZ, MD | Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7333761 | Background | Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available. | |
| 8466415 | Background | Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54. |
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| Cognitive abilities | Score with kettle test | Day 0 |
| Cognitive abilities | Score with kettle test | Day 180 |
| "Mesure des HAbitudes de VIE" (MHAVIE) | Score of "Mesure des HAbitudes de VIE" scale (MHAVIE) | Day 0 |
| "Mesure des HAbitudes de VIE" (MHAVIE) | Score of "Mesure des HAbitudes de VIE" scale (MHAVIE) | Day 180 |
| "Montreal Cognitive Assessment" (MoCA) | Score of "Montreal Cognitive Assessment" (MoCA) | Day 0 |
| "Montreal Cognitive Assessment" (MoCA) | Score of "Montreal Cognitive Assessment" (MoCA) | Day 180 |
| Aphasic Depression Rating (ADRS) | Score of Aphasic Depression Rating Scale (ADRS) | Day 0 |
| Aphasic Depression Rating (ADRS) | Score of Aphasic Depression Rating Scale (ADRS) | Day 180 |
| Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space | Score of "Bell test (test de barrage des cloches)" | Day 0 |
| Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space | Score of "Bell test (test de barrage des cloches)" | Day 180 |
| 17182981 | Background | Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20. |
| 17023243 | Background | Uswatte G, Giuliani C, Winstein C, Zeringue A, Hobbs L, Wolf SL. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the extremity constraint-induced therapy evaluation trial. Arch Phys Med Rehabil. 2006 Oct;87(10):1340-5. doi: 10.1016/j.apmr.2006.06.006. |
| 21474812 | Background | Veerbeek JM, Kwakkel G, van Wegen EE, Ket JC, Heymans MW. Early prediction of outcome of activities of daily living after stroke: a systematic review. Stroke. 2011 May;42(5):1482-8. doi: 10.1161/STROKEAHA.110.604090. Epub 2011 Apr 7. |
| 25533758 | Background | Rand D, Eng JJ. Predicting daily use of the affected upper extremity 1 year after stroke. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):274-83. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.039. Epub 2014 Dec 18. |